Not FDA-approved · not available for sale or prescription. Epitalon is not FDA-approved and is not available for sale or prescription. In July 2026, FDA staff recommended against adding it to the list of substances pharmacies may compound; FDA’s advisory committee voted 7–4, with 1 abstention, to recommend it anyway. The vote is advisory, and FDA has not acted on it.
- FDA
- Not approved. Epitalon held a US orphan-drug designation for retinitis pigmentosa from 2 Sep 2010 until it was withdrawn/revoked on 6 Jan 2016 (FDA briefing, citing FDA's orphan database). Reviewed at the PCAC on 24 Jul 2026 for insomnia: FDA proposed NOT adding epitalon (free base) or epitalon acetate; the committee voted 7 yes, 4 no, 1 abstain on each form to recommend inclusion (non-binding). No proposed or final FDA rule as of 26 Sep 2026.
- Compounding
- Nominated for the 503A Bulks List by LDT Health Solutions for the International Peptide Society (received 16 Nov 2018, FDA-2018-N-2973-0002) and by Wells Pharmacy Network (received 17 Dec 2020, FDA-2015-N-3534-0286). Held in 503A Category 2; both nominators withdrew on 14 Apr 2026, and epitalon now appears under 'nominated but withdrawn' on FDA's Category 2 page (updated 22 Apr 2026). FDA presented epitalon to the PCAC on 24 Jul 2026 and proposed NOT adding it; the committee voted 7-4-1 on each form to recommend inclusion (non-binding). As of 26 Sep 2026 FDA has published no proposed or final rule: the substance is not on the 503A bulks list (21 CFR 216.23, unchanged since 2019) and is not in 503A Category 1.
- Sport (WADA)
- Not named in the WADA 2026 Prohibited List. Because it has no known government approval for therapeutic use anywhere, it could plausibly be argued to fall under the general S0 'non-approved substance' catch-all in an anti-doping proceeding, although it is not explicitly named.
- Enforcement
- FDA warning letter to Tailor Made Compounding LLC, dated 2020-04-01, names Epitalon among bulk substances compounded without qualifying for a Section 503A exemption.
- Tailor Made Compounding LLC pleaded guilty in October 2020 to distributing unapproved new drugs, including Epitalon; on 24 Feb 2021 it was sentenced to three years' probation and forfeited $1,788,906.82, and its owner received probation, home incarceration and a $20,000 fine (U.S. Attorney's Office, E.D. Kentucky).